Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
NCT ID: NCT02034019
Last Updated: 2020-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
247 participants
INTERVENTIONAL
2014-02-28
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OTX-DP (Dexamethasone Punctum Plug)
Resorbable hydrogel drug delivery vehicle containing dexamethasone
Dexamethasone
Punctum Plug
PVPP (Placebo Punctum Plug)
Resorbable hydrogel drug delivery vehicle containing no drug
Punctum Plug
Interventions
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Dexamethasone
Punctum Plug
Eligibility Criteria
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Inclusion Criteria
* Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes
Exclusion Criteria
* Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
* Any intraocular inflammation in the study eye present during the screening slit lamp examination
18 Years
ALL
No
Sponsors
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Ocular Therapeutix, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Project Manager
Role: STUDY_DIRECTOR
Ocular Therapeutix
Locations
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Texan Eye / Keystone Research, Ltd.
Austin, Texas, United States
Countries
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Other Identifiers
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OTX-13-002
Identifier Type: -
Identifier Source: org_study_id
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